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A Study to Assess the Effects of Epetraborole on the QT Interval in Healthy Adult Subjects

NCT05995444 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-12-21

No results posted yet for this study

Summary

A single-center, 4-way crossover study to evaluate the effect of single therapeutic and supratherapeutic oral doses of epetraborole on the heart rate (HR) corrected QT interval (QTc) by assessing concentration-QT (C-QT) relationship using exposure-response modeling.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Epetraborole and matching placebo

Treatment A (Therapeutic): 500 mg epetraborole (2 x 250 mg tablets) and epetraborole matching-placebo (6 tablets)

DRUG

Epetraborole

Treatment B (Supratherapeutic): 2000 mg epetraborole (8 x 250 mg tablets)

DRUG

Placebo

Treatment C (Placebo control): Epetraborole matching-placebo (8 tablets)

DRUG

Moxifloxacin

Treatment D (Positive control): 400 mg moxifloxacin (1 x 400 mg tablet)

Sponsors & Collaborators

  • AN2 Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2023-07-26
Completion
2023-08-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05995444 on ClinicalTrials.gov